Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

NCT02578420 | Completed

• 1 other identifier: EKNZ 2015-246
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.

Conditions

Placebo Effect; Pain; Expectancy

Outcome Measures

Primary Outcomes (2)

• subjective intensity and unpleasantness ratings of heat pain tolerance

  Visual Analogue Scale (VAS)

  2 hours

• objective heat pain tolerance

  Temperatures

  2 hours

Secondary Outcomes (12)

• Expectancy of Relief Scale (ERS; Erwartungsfragebogen)

  2 hours

• Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF)

  2 hours

• multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF))

  2 hours

• sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD))

  2 hours

• Revised Life Orientation Test (LOT-R)

  2 hours

Study Arms (4)

open-label placebo

PLACEBO COMPARATOR

Participants (N=40) will have the information that they are receiving an inert cream (i.e. "placebo"). Placebo will be described as an inert or inactive cream, with no medication in it. Additionally, participants will be told that "placebo has been shown in rigorous clinical testing to produce significant mind-body self-healing processes." The placebo administration will be combined with the following scientific rationale/verbal suggestion: (a) placebos are effective analgesics, (b) classical conditioning as a possible mechanism of this effect, (c) compliance is important for outcome and (d) positive expectations increase placebo effects, but are not necessary.

Other: open-label placebo

deceptive placebo

SHAM COMPARATOR

Participants (N=40) will have the information that they are receiving an analgesic cream ("Antidolor, containing "Lidocain"), while in fact they will receive an inert cream, only. Antidolor will be described as an analgesic cream.

Other: deceptive placebo

control group

PLACEBO COMPARATOR

Participants (N=40) will have the information that they are receiving an inert control cream.

Other: open-label placebo

no treatment group

NO INTERVENTION

Participants (N=40) will be told that they are in the "no treatment group" and that they will not receive an analgesic cream.

Interventions

open-label placebo OTHER

Placebo Cream, openly described as "Placebo"

control group; open-label placebo

deceptive placebo OTHER

Placebo Cream, described as "Voltaren, containing Diclofenac"

deceptive placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female adults aged 18-65
• Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders
• Right-handedness (Oldfield, 1971),
• Willing to participate in study

You may not qualify if:

• Medicine or Psychology Students
• Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
• Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
• Insufficient German language skills to understand the instructions
• Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices
• Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
• Current or regular drug consumption (THC, cocaine, heroin, etc.)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University of Basel

Basel, 4055, Switzerland

Location

Related Publications (1)

• Locher C, Buergler S, Frey Nascimento A, Kost L, Blease C, Gaab J. Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial. BMJ Open. 2021 Aug 18;11(8):e053346. doi: 10.1136/bmjopen-2021-053346.

  PMID: 34408060 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Gaab, Prof

  Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 19, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

CH (1)